Study of XL647 Administered Orally Daily to Patients With Solid Tumors - Tabular View

Tracking Information
First Received Date ^ICMJE	June 12, 2006
Last Updated Date	July 30, 2009
Start Date ^ICMJE	July 2006
Estimated Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 3, 2008)	Evaluate safety, tolerability, and maximum tolerated dose of XL647 [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: June 12, 2006)	safety and tolerability
Change History	Complete list of historical versions of study NCT00336765 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 3, 2008)	Characterize pharmacokinetics and pharmacodynamic effects of XL647 [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ] Evaluate preliminary tumor response [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 12, 2006)	pharmacokinetics pharmacodynamic effects tumor response

Descriptive Information
Brief Title ^ICMJE	Study of XL647 Administered Orally Daily to Patients With Solid Tumors
Official Title ^ICMJE	A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of XL647 Administered Orally Daily to Subjects With Solid Tumors
Brief Summary	The purpose of this study is to assess the safety and tolerability of the multiple receptor tyrosine kinase (RTK) inhibitor (including EGFR, VEGFR2, ErbB2, and EphB4) XL647 when given orally daily to adults with advanced solid tumors.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Condition ^ICMJE	Cancer
Intervention ^ICMJE	Drug: XL647
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	December 2007
Estimated Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subject has histologically confirmed malignancy that is metastatic or unresectable Subject has disease that is assessable by tumor marker, physical, or radiologic means Subject is at least 18 years old Subject has an ECOG performance status ≤ 2 (Karnofsky ≥ 60%) Subject has a life expectancy ≥ 3 months Subject has normal organ and marrow function Subject gives written informed consent Subjects must use an accepted method of contraception during the study Female subjects of childbearing potential must have a negative pregnancy test Exclusion Criteria: Subject has received anticancer treatment within 30 days of first dose of XL647 Subject has received another investigational agent within 30 days of first dose of XL647 Subject has known brain metastases Subject has corrected QT interval (QTc) of > 0.45 seconds Subject is currently receiving anticoagulation therapy with warfarin Subject has uncontrolled intercurrent illness Subject is pregnant or breastfeeding Subject has known HIV
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00336765
Responsible Party	Charles W. Finn, PhD, President and CEO, Symphony Evolution, Inc.
Study ID Numbers ^ICMJE	XL647-002
Study Sponsor ^ICMJE	Symphony Evolution, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Symphony Evolution, Inc.
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP